NCT03756363

Brief Summary

No clinical evidence has been yet published regarding the comparison of postoperative pain after removal of the root canal fillings with or without solvent. The aim of this study was to evaluate the effect of combined usage of ProTaper retreatment instruments and a gutta-percha solvent, on the postoperative pain intensity after retreatment.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 26, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

July 8, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

November 26, 2018

Last Update Submit

July 3, 2019

Conditions

Root Canal InfectionPain

Keywords

Postoperative painDebris extrusionFilling removalsolvent

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain after removal of gutta-percha with or without solvent

    Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.

    24 hours postoperatively

Secondary Outcomes (2)

  • Postoperative pain after removal of gutta-percha with or without solvent

    24 to 48 hours postoperatively

  • Postoperative pain after removal of gutta-percha with or without solvent

    48 to 72 hours postoperatively

Study Arms (2)

Non-solvent

EXPERIMENTAL

Non-solvent use of a rotary retreatment system

Procedure: Non-solvent

Solvent

EXPERIMENTAL

Solvent use in combination with a rotary retreatment system

Procedure: Solvent

Interventions

Non-solventPROCEDURE

Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.

Non-solvent
SolventPROCEDURE

Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.

Solvent

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patient who has a failed root canal treatment.
  • Asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic apical periodontitis.
  • Patients agreed to parcitipate in the study

You may not qualify if:

  • Overfilled teeth,
  • teeth with intraradicular posts,
  • existence of a sinus tract,
  • consumption of antibiotics or analgesics within one month,
  • pregnancy,
  • history of trauma,
  • traumatic occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozgur Genc Sen

Van, 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • Genc Sen O, Erdemir A, Canakci BC. Effect of solvent use on postoperative pain in root canal retreatment: a randomized, controlled clinical trial. Clin Oral Investig. 2020 Jan;24(1):257-263. doi: 10.1007/s00784-019-02948-3. Epub 2019 May 15.

    PMID: 31093742DERIVED

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Solvents

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

Specialty Uses of ChemicalsChemical Actions and Uses

Study Officials

  • Ozgur G Genc Sen

    Yuzuncu Yil University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

  • Ali G Erdemir

    Yuzuncu Yil University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 26, 2018

First Posted

November 28, 2018

Study Start

October 22, 2018

Primary Completion

January 5, 2019

Study Completion

January 10, 2019

Last Updated

July 8, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)